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Efecto de la distribución del tiempo de residencia de la prensa de tabletas en la trazabilidad del material en un
Peter Boehling1, Johan Remmelgas1, Johannes Poms1
1Research Center Pharmaceutical Engineering, Graz, Austria.
International journal of pharmaceutics
|February 8, 2026
Resumen
La fabricación de compresión directa continua mediante mini lotes (CDC mediante MBB) requiere la comprensión del flujo de materiales. Este estudio cuantifica la distribución del tiempo de residencia (RTD) en las prensas de tabletas, revelando la mezcla y permitiendo estrategias optimizadas de desviación de materiales.
Área de la Ciencia:
- Fabricación farmacéutica
- Ingeniería de procesos
- Ciencia de materiales
Sus antecedentes:
- La compresión directa continua mediante mini lotes (CDC mediante MBB) es una tecnología emergente de fabricación farmacéutica.
- El seguimiento de materiales en líneas de CDC mediante MBB es fundamental para el control del proceso, especialmente dentro de la prensa de tabletas.
- La evaluación de la distribución del tiempo de residencia (RTD) en la prensa de tabletas es esencial después de la etapa inicial de mezcla.
Objetivo del estudio:
- Desarrollar un marco metodológico para caracterizar la RTD en una prensa de tabletas dentro de un proceso de CDC mediante MBB.
- Cuantificar la mezcla entre mini lotes (MB) durante el proceso de compresión.
- Evaluar la efectividad de diferentes estrategias de desviación de materiales basadas en información de RTD.
Principales métodos:
- Caracterización experimental de la RTD utilizando un cambio escalonado de trazador de ácido tartárico y espectroscopía Raman de transmisión.
- Modelado in silico utilizando simulaciones de método de elementos discretos (DEM), corroborado con datos experimentales.
- Prueba basada en simulación de estrategias de desviación de materiales conservadoras versus inteligentes.
Principales resultados:
- Los resultados experimentales demostraron una mezcla significativa entre mini lotes (MB) adyacentes.
- Las simulaciones basadas en RTD cuantificaron esta mezcla, mostrando que las tabletas son mezclas de múltiples MB.
- Se descubrió que las estrategias inteligentes de desviación de materiales reducen significativamente el material no conforme después de la perturbación.
Conclusiones:
- La caracterización de la RTD de la prensa de tabletas es clave para comprender la dinámica del proceso en CDC mediante MBB.
- La información de RTD facilita el desarrollo de estrategias efectivas de muestreo y desviación de materiales.
- El marco y los hallazgos presentados son aplicables a varias configuraciones de prensas de tabletas.
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